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Page 1
Recommendations on incurred sample stability (ISS) by GCC.
Lowes S, LeLacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Zimmer J, Caturla MC, Couerbe P, Awaiye K, Fatmi S, Farmen R, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Zhang T, Pasas-Farmer S, Garofolo W, Moussallie M, Rocci M, Allinson J, Gouty D, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Hayes R, Bouhajib M, Stipancic M, Nicholson R, Nehls C, Warren M, Karnik S, Houghton R, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Lowes S, et al. Among authors: moussallie m. Bioanalysis. 2014 Sep;6(18):2385-90. doi: 10.4155/bio.14.155. Bioanalysis. 2014. PMID: 25384591
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
Lowes S, Boterman M, Doig M, Breda M, Jersey J, Lelacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Zimmer J, Caturla MC, Couerbe P, Maltas J, Steffen R, Petrilla J, Safavi A, Awaiye K, Bhatti M, Sheldon C, Schiebl C, Struwe P, Turk D, Sangster T, Pattison C, Fast D, Goodwin L, Kamerud J, Dinan A, Mamelak D, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Folguera L, Zimmer D, Zimmermann T, Pawula M, Moussallie M, de Souza Teixeira L, Rocha T, Allinson J, Jardieu P, Tang D, Gouty D, Wright L, Truog J, Lin J, Yamashita Y, Khan M, Liu Y, Xu A, Lundberg R, Cox C, Breau A, Hayes R, Bigogno C, Schoutsen D, Dilger C, Jonker J, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Nicholson R, Jenkins R, Warren M, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, Fang X. Lowes S, et al. Among authors: moussallie m. Bioanalysis. 2012 Sep;4(17):2117-26. doi: 10.4155/bio.12.192. Bioanalysis. 2012. PMID: 23013394
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Rocci M, Lowes S, Shoup R, Garofolo F, Farmen R, Zhang T, Allinson J, Gouty D, Hayes R, Nicholson R, Houghton R, Dumont I, LeLacheur R, Zimmer J, Cruz Caturla M, Couerbe P, Awaiye K, Fatmi S, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Pasas-Farmer S, Garofolo W, Moussallie M, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Bouhajib M, Stipancic M, Nehls C, Warren M, Karnik S, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, Watson A. Rocci M, et al. Among authors: moussallie m. Bioanalysis. 2014 Oct;6(20):2713-20. doi: 10.4155/bio.14.231. Bioanalysis. 2014. PMID: 25413703 No abstract available.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Islam R, Kar S, Ritzén H, Hays A, Tayyem R, Barry C, Keyhani A, Zimmer J, Cruz Caturla M, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Hughes N, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Cape S, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Garofolo W, Savoie N, Brown M, Rhyne P, Hristopoulos G, Xu A, Goodwin L, Spriggs F, Xu A, Awaiye K, Hayes R, St Charles J, Bouhajib M, DiMarco C, DiMarco L, Savu SR, Bennett P, Kakkanaiah V, Nehls C, Stouffer B, Tabler E, Briscoe C, Karnik S, DuBey I, Kulagina N, Lindsay J, Beaver C, Williard C, Wang H, Feng H, Malone M, Wells E, Fang X, Moussallie M. Islam R, et al. Among authors: moussallie m. Bioanalysis. 2019 Apr;11(7):645-653. doi: 10.4155/bio-2019-0072. Epub 2019 Apr 17. Bioanalysis. 2019. PMID: 30993999
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Briscoe C, Hughes N, Hayes R, Islam R, Bennett P, Stouffer B, Cape S, Rhyne P, Beaver C, Charles JS, Kakkanaiah V, Xu A, Caturla MC, Spriggs F, Tayyem R, Barry C, Keyhani A, Zimmer J, Couerbe P, Warren M, Khadang A, Bourdage J, Lindley K, Williams D, Sheldon C, Satterwhite C, Vija J, Yu M, Boulay I, Stamatopoulos J, Lin J, Estdale S, Thomas E, Dinan A, MacNeill R, Xiao YQ, Matassa L, Garofolo W, Savoie N, Hristopoulos G, Xu A, Goodwin L, Awaiye K, Ritzén H, Bouhajib M, Marco CD, Savu SR, Nehls C, Tabler E, Hays A, Karnik S, Brown M, Lowes S, DuBey I, Kulagina N, Lindsay J, Williard C, Wang H, Malone M, Wells E, Fang X, Moussallie M. Briscoe C, et al. Among authors: moussallie m. Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19. Bioanalysis. 2019. PMID: 31319683
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. Lowes S, et al. Among authors: moussallie m. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, Fang X. Boterman M, et al. Among authors: moussallie m. Bioanalysis. 2012 Mar;4(6):651-60. doi: 10.4155/bio.12.18. Bioanalysis. 2012. PMID: 22452256 No abstract available.
4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
Lowes S, Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, Fang X. Lowes S, et al. Among authors: moussallie m. Bioanalysis. 2012 Apr;4(7):763-8. doi: 10.4155/bio.12.48. Bioanalysis. 2012. PMID: 22512795
Formation of a Global Contract Research Organization Council for Bioanalysis.
Premkumar N, Lowes S, Jersey J, Garofolo F, Dumont I, Masse R, Stamatiou B, Caturla MC, Steffen R, Malone M, Offman E, Samuels T, Oldfield P, Di Donato L, Fast D, Tang D, Moussallie M, Doughty J, Rocci M, Buonarati M, Gouty D, Dadgar D, Stamatopoulos J, Breau A, Ntsikoussalabongui B, Bouhajib M, Nicholson B, Tacey R, Ketelaar P, Briscoe C, Karnik S, Wieling J, Smith JK, Reid MJ, Lelacheur R, Chapdelaine J, Fatmi S, Sayyarpour F, Fang X, Cook J, Browne D. Premkumar N, et al. Among authors: moussallie m. Bioanalysis. 2010 Nov;2(11):1797-800. doi: 10.4155/bio.10.165. Bioanalysis. 2010. PMID: 21083485 No abstract available.
13 results